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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86280

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

Open FDA event record

Event summary

Timeline bucket
August 19, 2020
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
BAYSHORE PHARMACEUTICALS

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

2 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 2

Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-128-10

D-1543-2020
Recall number
D-1543-2020
Initiated
August 19, 2020
Classification
Class II
Status
Terminated
Recalling firm
BAYSHORE PHARMACEUTICALS
Quantity
594 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations

Code information

Lot #18641; Exp. 05/2021

Distribution pattern

nationwide

drug · product 2 of 2

Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-129-01

D-1544-2020
Recall number
D-1544-2020
Initiated
August 19, 2020
Classification
Class II
Status
Terminated
Recalling firm
BAYSHORE PHARMACEUTICALS
Quantity
3984 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations

Code information

Lot #18657, Exp. 05/2021

Distribution pattern

nationwide