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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88843

8 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 13, 2021
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Ultra Seal Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

8 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 8

PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case, Material # 11161, Mfg. for Respond Industries First Aid, Mason, OH 45040 (Shipping Label)

D-0070-2022
Recall number
D-0070-2022
Initiated
October 13, 2021
Classification
Class III
Status
Terminated
Recalling firm
Ultra Seal Corporation
Quantity
2,484,274 tablets

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out-of-Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Code information

Lot #: AK-9336, exp. date 21-Oct; K9406, AK-9407, exp. date 21-Dec; K-9860, exp. date 22-Oct; AK-1057, exp. date 23-Feb

Distribution pattern

Nationwide in the USA.

drug · product 2 of 8

Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets/pk, packaged in 10,000 packets, PO# 8967, Mfg. for Tellus/The Provision First Aid Line (Shipping Label)

D-0071-2022
Recall number
D-0071-2022
Initiated
October 13, 2021
Classification
Class III
Status
Terminated
Recalling firm
Ultra Seal Corporation
Quantity
1,367,525 tablets

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out-of-Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Code information

Lot #: AK-9455, exp. date 22-Jan; AK-1109, AK-1110, exp. date 23-Mar; K-9821, exp. date 22-Sep

Distribution pattern

Nationwide in the USA.

drug · product 3 of 8

ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets per/package, Packaged in a) 50-count packages/carton, b) 125-count packages/carton, PA-ESF 1414Z, Dist. by: Zee Medical Distributors, LLC Mason, OH 45040 (Shipping Label)

D-0072-2022
Recall number
D-0072-2022
Initiated
October 13, 2021
Classification
Class III
Status
Terminated
Recalling firm
Ultra Seal Corporation
Quantity
1,968,150 tablets

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out-of-Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Code information

Lot #: AK-9547, exp. date 22- Apr; AK-9941, exp. date 22-Dec

Distribution pattern

Nationwide in the USA.

drug · product 4 of 8

AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in 10,000 Packets/Case, PO# 11938, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989 (Shipping Label )

D-0073-2022
Recall number
D-0073-2022
Initiated
October 13, 2021
Classification
Class III
Status
Terminated
Recalling firm
Ultra Seal Corporation
Quantity
1,480,981 tablets

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out-of-Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Code information

Lot #: K-1278, exp. date 23-Jul; K-9371, AK-9463, exp. date 21-Nov; AK-9821, AK-9819, exp. date 22-Sep; 1107, exp. date 23-Mar.

Distribution pattern

Nationwide in the USA.

drug · product 5 of 8

North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg) tablets, 2 tablets per packet, Packaged in 5,000 Packets/Case, PO# B121242, Item# 853500-01, Dist. By Honeywell Safety Products USA, Smithfield, RI 02917

D-0074-2022
Recall number
D-0074-2022
Initiated
October 13, 2021
Classification
Class III
Status
Terminated
Recalling firm
Ultra Seal Corporation
Quantity
250,000 tablets

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out-of-Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Code information

Lot #: AK-9371, exp. date 21-Nov

Distribution pattern

Nationwide in the USA.

drug · product 6 of 8

Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (Shipping Label)

D-0075-2022
Recall number
D-0075-2022
Initiated
October 13, 2021
Classification
Class III
Status
Terminated
Recalling firm
Ultra Seal Corporation
Quantity
991,310 tablets

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out-of-Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Code information

Lot #: AK-9457, exp. date 22-Jan; AK-9521, exp. date 22-Mar; AK-9959, exp. date 22-Dec; AK-1017, exp. date 23-Jan

Distribution pattern

Nationwide in the USA.

drug · product 7 of 8

Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, Material# 111519, Mfg. for: Cintas First Aid & Safety, Mason, OH 45040 (Shipping Label)

D-0076-2022
Recall number
D-0076-2022
Initiated
October 13, 2021
Classification
Class III
Status
Terminated
Recalling firm
Ultra Seal Corporation
Quantity
42,394,018 tablets

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out-of-Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Code information

Lot #: K-9335, AK-9419, exp. date 21-Oct; AK-9369, exp. date 21- Nov; AK-9403, exp. date 21-Dec; AK-9452, K-9455, 9455, exp. date 22-Jan; AK-9586, exp. date 22-Feb; AK-9525, AK-9526, AK-9639, exp. date 22-Mar; AK-9568, AK-9569, AK-9567, AK-9692, exp. date 22-Apr; AK-9615, exp. date 22-May; AK-9666, exp. date 22-Jun; AK-9714, K-9714, AK-9718, K-9718, 9718, exp. date 22-Jul, AK-9719, exp. date 22-Jul; AK-9771, AK-9765, AK-9769, exp. date 22-Aug; AK-9822, AK-9818, exp. date 22-Sep; AK-9860, exp. date 22-Oct; AK-9957, exp. date 22-Dec; AK-1011, K-1014, 1014, AK-9489, exp. date 23-Jan; 1055, K-1057, 1057, AK-1058, exp. date 23-Feb; AK-1108, AK-1113, K-1199, AK-1199, exp. date 23-May; AK-1240, 1240, exp. date 23-Jun; AK-9335, exp. date 10/21; AK-9406, exp. date 21-Dec; AK-1278, exp. date 23-Jul; K-1240, exp. date 23-Jun

Distribution pattern

Nationwide in the USA.

drug · product 8 of 8

Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, PO# 19540, Mfg. for: Afassco Minden, NV 89423 (Shipping Label)

D-0077-2022
Recall number
D-0077-2022
Initiated
October 13, 2021
Classification
Class III
Status
Terminated
Recalling firm
Ultra Seal Corporation
Quantity
519,600 tablets

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out-of-Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Code information

Lot #: 9819, K-9819, exp. date 22-Sep

Distribution pattern

Nationwide in the USA.