The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1033-2020·Announced 2020-03-25

Sun Pharmaceutical Recalls Doxycycline Capsules Due to Manufacturing Deviations

Sun Pharmaceutical Industries is recalling 172,320 bottles of Doxycycline Capsules, 100 mg, because they were not manufactured under Current Good Manufacturing Practice conditions.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source metadata explicitly identifies the agency classification as Class II. According to the rubric, FDA Class II recalls with potential for serious adverse health consequences are classified as Severe (Score 4).

Plain-English summary

Sun Pharmaceutical Industries, Inc. is recalling 172,320 bottles of Doxycycline Capsules, USP, 100 mg, 50-count bottles. The product is a prescription-only medication manufactured by Ohm Laboratories Inc. and distributed by Sun Pharmaceutical Industries, Inc. The affected product is identified by NDC 63304-616-50.

The recall was initiated because the doxycycline capsules were not manufactured under Current Good Manufacturing Practice (CGMP) conditions. This classification indicates a potential risk of adverse health consequences, though the specific nature of the manufacturing deviation is not detailed in the source text.

The affected lots include 3983720 (Exp 10/2020); 3990461, 3990464, 3990465, 3990466, 3990470 (Exp 11/2020); AA42499, AA42510, AA44468, AA44470 (Exp 04/2021); AA55073, AA55074, AA55075 (Exp 05/2021); and AA61486 (Exp 06/2021). The product was distributed nationwide in the USA. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If found, the product should be returned to the pharmacy or point of purchase for a refund or replacement.

The recalled product

Product
DOXYCYCLINE (DOXYCYCLINE)
Brand
DOXYCYCLINE
Manufacturer
Sun Pharmaceutical Industries, Inc.
Category
Drug — Antibiotic
Hazard
Affected units
172,320

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (19)

  • Lot #: 3983720
  • Exp 10/2020
  • 3990461
  • 3990464
  • 3990465
  • 3990466
  • 3990470
  • Exp 11/2020
  • AA42499
  • AA42510
  • AA44468
  • AA44470
  • Exp 04/2021
  • AA55073
  • AA55074
  • AA55075
  • Exp 05/2021
  • AA61486
  • Exp 06/2021

UPCs (1)

  • 0363304614015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Sun Pharmaceutical Industries, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same brand · DOXYCYCLINE

Same manufacturer · Sun Pharmaceutical Industries, Inc.

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Same hazard · cgmp deviation

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